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SFDA to Approve another 4 Testing Institutions for Cosmetics

The SFDA-approved testing institutions are accountable to undertake tests for cosmetic products/new ingredients and issue testing reports for companies applying for cosmetic administrative licensing in China. With the growing demand of cosmetic testing, another 4 units (marked red in Table 1) have been approved to undertake tests since 1 Nov 2012.

Pursuant to Article 3 of Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions, there are two types of institutions:

  • hygiene safety testing institutions to perform all microbiological, hygienic chemical and toxicological tests;
  • human safety testing institutions to conduct human safety tests (including human skin patch test and using test) and cosmetic sunscreens efficacy test.

According to the announcement No. 18 and No. 86 of 2011, 17 hygiene safety testing institutions and 6 human safety testing institutions have been approved in 2011. The four newly approved ones belong to the first category . 

Every testing institution bears a unique serial number. The SFDA will supervise the testing quality by requiring monthly and annual reports from institutions, in addition to non-scheduled on-site inspections. 

Table 1: List of 27 SFDA-approved testing institutions for cosmetics

Type

Testing Institution

Serial Number

Hygiene safety testing institution

(microbiological test, hygienic chemical test,

toxicological test)

 Institute of Environmental Health

and Related Product Safety, China CDC

001

Beijing CDC

002

Liaoning CDC

003

Shanghai CDC

004

Jiangsu CDC

005

Zhejiang CDC

006

Guangdong CDC

007

Sichuan CDC

008

Beijing institute for Drug Control

014

Shanghai institute for Food and Drug Control

015

Guangdong institute for Drug Control

016

Zhejiang Institute for Food and Drug Control

018

Shandong Institute for Food and Drug Control

019

Fujian Provincial Institute for Drug Control

020

Guangzhou Institute for Drug Control

021

Shenzhen Institute for Drug Control

022

Hubei Provincial Center for Disease Control and Prevention

023

National Institute for Food and Drug Control

024

Liaoning Institute for Food and Drug Control

025

Guangxi Institute for Food and Drug Control

026

Xiamen Institute for Drug Control

027

Human safety testing institutions

(human safety test and in vivo test of UV protection efficacy of cosmetic sunscreens)

General Hospital of Chinese People's Liberation Army Air Force

009

Shanghai Skin Disease Hospital

010

The third Affiliated Hospital of San Yat-sen University

011

West China Hospital of Sichuan University

012

The first hospital of China Medical University

013

kin Disease Hospital of Chinese Academy of Medical Sciences

017

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Table 2: Compulsory testing items of  hygiene safety testing institutions

Testing Category

Compulsory Testing Item

Microbiological

Aerobic bacterial count

Fecal coliforms

Staphylococcus aureus

Pseudomonas aeruginosa

Molds and yeast count

Hygienic chemical

Mercury

Arsenic

Lead

Methanol

PH

Formaldehyde

Thioglycollic Acid

Hydroquinone and Phenol

Chlormethine and Cantharidin

Sexual Hormones 

UV filters

Oxidative Hair Dyes

α-Hydroxy Acid 

Antidandruff agent 

Antibiotics 

Toxicological

Acute oral toxicity test

Acute dermal toxicity test

Skin irritation/corrosion test

Eye irritation/corrosion test

Skin sensitization test

Skin phototoxicity test

Salmonella typhimurium/reverse mutation assay

In Vitro Mammalian Cells Chromosome Aberration Test

In Vitro Mammalian Cell Gene Mutation Test

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Table 3: Optional testing items of hygiene safety testing institutions

Testing Category

Optional Testing Item

Hygienic chemical

Anti UVA parameter-critical wavelength

Free Hydroxide

Cadmium

Total Selenium

Boric Acid and Borate

Selenium Disulfide

Preservatives

Vitamin D2, Vitamin D3

Dissolvable zinc salt

Toxicological

In Vivo Mammalian Bone Marrow Cell Chromosome Aberration Test

Mammalian Erythrocyte Micronucleus Test

Testicle Cells Chromosome Aberration Test

Subchronic Oral Toxicity Test

Subchronic Dermal Toxicity Test

Teratogenicity Test

Combined Chronic Toxicity/Carcinogenicity Test

Metabolic toxicity test

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Table 4: Testing items of human safety testing institutions

Testing Category

Testing Item

Human safety test

Human Skin Patch Test

Safety Evaluation of Using Tests of Cosmetics on Human Body

Tests in vivo of UV Protection Efficacy of Cosmetic Sunscreens

SPF test  

PFA test  

Waterproof performance test

 

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Reference Links

  Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions

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